Adverse Incident, Advisory Notices & Recall

Alert - means the removal of specific batch/batches of a medicinal product from the market for reasons relating to deficiencies in the quality, safety or efficacy.

Adverse event - means the removal of specific batch/batches of a medicinal product from the market for reasons relating to deficiencies in the quality, safety or efficacy.

Recall - means the removal of specific batch/batches of a product from the market for reasons relating to deficiencies in the quality, safety or efficacy

6. Abbreviations

SOP – Standard Operating Procedure

DoC – Declaration of Conformity

COA – Certificate of Analysis

HCR - Holder Certificate Registration

7. References

ISO13485 Clause 8.2.3 & 8.3

SOP Non Conformance Corrective Action

SOP Post Market Surveillance

8. Procedure

8.1 Adverse Incidents

1. Any Adverse event must be recorded and follow the SOP Non Conformance Corrective Action
2. The Authorised Representative, independent of the sales and marketing organization, is designated as responsible for execution and co-ordination of recalls and is supported by the Responsible Person to handle all the aspects of the recalls with the appropriate degree of urgency.
3. This Responsible Person must always be made aware of any recall operation, who will investigate and determine the class and type of Recall.
4. The Recall process must be initiated promptly and at any time and therefore there is the 24 hour contact number for the Managing Director as per SAHPRA timelines

5. Reporting to regulatory authorities; If applicable regulatory requirements require notification of complaints that meet specified reporting criteria of adverse events or issuance of advisory notices, the companies follows notification to the appropriate regulatory authorities as per point 6

6. The Regulatory Authority maybe informed promptly by e-mail or telephone call if products are intended to be recalled because they are, or are suspected of, being defective. Refer http://www.sahpra.org.za/acts-and-regulations/

GENERAL TIMELINES ref GHTF/SG2/N6R3:2002 New MDR EU refer Article 73 & 80

refer website http://www.imdrf.org/documents/documents.asph and CE requirements located http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en

8.2 Advisory notices (8.5.1.3) regarding non conforming product or Recall

The organization issues advisory notices in accordance with applicable regulatory requirements and the attached letter format.

Letterhead: (Copy & Paste into a document)

Date

Regulator / Customer

Address etc

Re: Advisory Notice : Product : batch

Description of the medical device / product and model designation,

The serial numbers or other identification (for instance batch or lot numbers) of the medical device or product concerned,

The reason for the issue of the notice,

Any advice regarding possible hazards, and any consequent actions to be taken.

Yours Sincerely

PSO

The advisory notices must be reported to regulatory authorities if applicable and as identified by the appointed PSO refer PharmacoVigilance and Post market surveillance SOP.
The notice includes medical devices that need to be corrected in order to be safe and perform as intended, as well as nonconforming devices that cannot be corrected and have to be removed from the market.
Any specific regulatory procedures for processing advisory notices and recall must be followed as required by the regulatory authority.
The nature and seriousness of the hazard or nonconformity, the intended use of the medical device, and the potential for patient injury or failure to meet regulatory requirements, will determine whether it will be necessary to issue an advisory notice and to report to national or regional regulatory authorities.
These factors also determine the urgency and extent of the action.
The procedure for generating, authorizing and issuing an advisory notice is that the PSO will activate the process and in the event of the absence of the PSO then the MD will initiate with consultation to the PSO and regulatory authorities.
A team is con-coordinated to determine the affected products, the disposition of returned product (e.g. rework, repackage, scrap), and the communication system (which includes the necessity to report to local or national authorities), the points of contact and the methods of communication between the organization and national or regional regulatory authorities.
If a medical device is returned to the organization, the progress of agreed corrective actions is monitored by the team and, if appropriate, the quantities of product physically returned to the organization or scrapped locally or corrected locally is reconciled.

8.3 CONSUMER PROTECTION

1. The Consumer Protection Act - a recall may be notified refer; https://www.gov.za/documents/consumer-protection-act
  1. The National Consumer Commission (NCC) re http://www.thedti.gov.za/agencies/ncc.jsp
  2. The National Consumer Commission (NCC) is established in terms of section 85 of the Consumer Protection Act No. 68 of 2008, as an organ of state within the Public administration, and as an institution outside public service with jurisdiction throughout the Republic of South Africa. The NCC is charged with the responsibility to enforce and carry out the functions assigned to it in terms of the Act, which aims to:
2. Promote a fair, accessible and sustainable marketplace for consumer products and services, and for that purpose;
3. Establish national norms and standards relating to consumer protection;
4. Provide for improved standards of consumer information;
5. Prohibit certain unfair marketing and business practices;
6. Promote responsible consumer behaviour; and

7. Promote a consistent legislation and enforcement framework relating to consumer transactions. Commissioner (Acting) :

8.4 RECALLS

1. The distribution records are requested from the Logistics Manager, who is to make them readily available to the Authorised Representative / Responsible Person, and should contain sufficient information on wholesalers and directly supplied customers (with addresses, phone and/or fax numbers inside and outside working hours, batches and amounts delivered), including those for exported products and medical samples.
2. Recalled products are identified and stored separately in a secure area while awaiting a decision on their fate; as per Rejected Materials
3. Customers are notified by letter from the Responsible Person and CEO.
4. The progress of the recall process is recorded and a final report issued, including a reconciliation between the delivered and recovered quantities of the products.
5. The effectiveness of the arrangements for recalls should be evaluated from time to time through Self inspection / Internal auditing or a mock recall is initiated and recorded.

8.4.1 CLASSIFICATION OF RECALLS

Recalls are classified into both the class according to the level of health hazard involved (risk to the patient) and type which denotes the depth or extent to which the product should be recalled from the distribution chain, e.g. Class I, Type C recall, etc.

Class I

Class I is for defective/dangerous/potentially life-threatening MEDICAL DEVICE / IVDs that predictably or probably could result into serious health risk/adverse events or even death.

Class II

Class II is for MEDICAL DEVICE / IVDs that possibly could cause temporary or medically reversible adverse health problem or mistreatment.

Class III

Class III is for MEDICAL DEVICE / IVDs that are defective and are unlikely to cause any adverse health reaction or which do not comply with the requirements of Act 101 of 1965 in terms of the requirements of printed packaging material, product specification, labeling, etc.

Type A

A type A recall is designed to reach all suppliers of MEDICAL DEVICE / IVDs (all distribution points) i.e. wholesalers throughout the country, directors of hospital services (private as well as state hospitals), retail outlets, doctors, nurses, pharmacists, authorised prescribers and dispensers and individual customers or patients through media release (radio, television, regional and national press).

Action: Recall letter to all distribution points plus media release.

Type B

A type B recall is designed to reach wholesalers throughout the country, directors of hospital services (private as well as state hospitals), retail outlets, doctors, nurses, pharmacists, authorised prescribers and dispensers.

Action: Recall letter to all distribution points.

Type C

A type C recall is designed to reach wholesale level and other distribution points (e.g. pharmacies, doctors, hospitals) this can be achieved by means of a representatives calling on wholesalers and/or retail outlets. If it is known where the product in question had been distributed to, specific telephone calls or recalls letters to arrange for the return of the product could be made.

Action: Specific telephone calls, recall letters to representatives calling at distribution points if known where the MEDICAL DEVICE / IVDs have been distributed.

NOTE: Decisions on the class and type of a recall to be initiated are a matter of the MEDICAL DEVICE / IVDs Control Council and MEDICAL DEVICE / IVDs Regulatory Affairs in consultation with a holder of the registration certificate and shall be based on the evidence and/or expert opinion of the REGULATORY AUTHORITY and HCR. In the event of greater urgency e.g. after hours or over weekends, the decision to recall can be initiated by the HCR.

8.4.2 RECALL LETTER CONTENTS

Recall communication from holder of the registration certificate to the distribution chain should be written in accordance with the following directive:

a) Shall be on the company's letterhead and signed by the Managing Director or any authorised person/responsible pharmacist.

b) The heading should indicate that it is an "Urgent MEDICAL DEVICE / IVD Recall".

c) Name of product, dosage form, strength, registration number, pack size, batch number(s), expiry date and any other relevant information necessary to allow absolute identification.

d) Nature of the defect (be brief and to the point).

e) Urgency of the action.

f) Reason for the action (reason for recall).

g) Indication of a health risk (this should also state exactly what the product may do if taken, i.e. side-effects).

h) Provide specific information on what should be done in respect of the recalled MEDICAL DEVICE / IVD. Method of recovery or product correction, which will be used.

i) Where necessary a follow-up communication shall be sent to those who failed to respond to the initial recall communication.

j) A request to retain the letter in a prominent position for one month in case stock is in transit (where applicable).

k) Where recalled stock has been distributed to a limited number of hospitals and the recall letter is not to be sent to all hospitals in the province, the letter should include the following:

l) "If any of the recalled stock could have been transferred from your hospital to another, please let that hospital know or alternatively inform our company so that we can make contact with the hospital supplied from your hospital".

8.4.3 MOCK RECALL

Mock recall may be initiated to measure the effectiveness of a recall - record in Google Drive Folder Regulatory

PROCEDURE FOR SETTING UP A MOCK RECALL

1. The Authorised Representative sets out the plan and starts the process as per below – taking note of the date and times when each step is started and finalised.

2. The Authorised Representative selects a product from a random Sales Invoice

3. The Authorised Representative then requests the distribution records of the product selected from the Warehouse Manager.

4. The distribution records contain the information required to locate the selected product (being addresses / phone contact details / batch numbers / serial numbers and quantity)

5. The Warehouse Manager also then locates the product selected which is still stored in the warehouse and identifies the quantities and where they are stored.

6. The Authorised Representative then drafts an email to SAHPRA (this is just a mock email) but all the information and classification and risk are identified in the email as to the extent of the recall required. This information is found under section 8.2 Advisory Notices (8.5.1.3) regarding non conforming product/s as above.

7. Once this has been done then a letter / email is compiled and sent to all the customers / suppliers who have been involved in the selected product – either in sending it or receiving from the organisation. (note that this is a mock email). The letter / email needs to cover all the following steps as per section 8.4.2 Recall Letter Contents as above.

8. The customers respond to the email / letter (this is once again a mock response)

9. The Authorised Representative now formulates a report for SAHPRA – this report will have the following information:

a. The progress of the recall process – which is recorded giving dates and times of each step and a final report is issued which includes the reconciliation of the all products that were selected – those delivered and those still stored in the warehouse so that all items are accounted for.

b. If the medical device is returned to the organisation – the agreed corrective action is monitored by the team in place and dealt with accordingly

10. The Authorised Representative completes a recall report with timelines as to how long it took from start of the process to the finalisation. All these documents are stored and saved in the Google Drive Folder – Regulatory then a sub folder – Mock Recall Documents

9. Risk Based Approach

In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION

Risk Based Approach Report

[Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document]

9.1 Trend Analysis and Continual Improvement

The analytical reviews of supplier performance, and any other quality related matters, are reported to management and as part of the input to management review refer Data Analysis

The Trend analysis may identify any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.

10. Revision History

Revision 15, 19.08.2021 - AA - Updating Information

Revision 14, 21.07.2021 - TNA - addition of the mock recall procedure under item 8.4.3 and updating no 4 Responsibilities

Revision 13, 03.05.2021 - AA Approved

Revision 12, 23.04.2021 - TNA - Updating the SOP to the new format. Risk Based Approach / Approval / Scope / Records and Revision History / numbering.

Revision 11, Digitally signed on 18.06.2020 by AA

Revision 1-10, unknown due to google site change to new google site

11. RECORDS

Name Retained by/ in Retention period Hard copies Destroyed by

Mock Recall Google Drive 5 years Management Representative deletion

Recall documentation Google Drive 5 years Authorised Representative deletion